Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? (ESTIMABL2)
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| ClinicalTrials.gov Identifier: NCT01837745 |
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Recruitment Status :
Active, not recruiting
First Posted : April 23, 2013
Last Update Posted : May 17, 2023
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Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
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Brief Summary:
Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).
The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Risk Differentiated Thyroid Cancer | Drug: rhTSH stimulation Drug: I131 Other: Follow up | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 776 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? |
| Actual Study Start Date : | May 13, 2013 |
| Actual Primary Completion Date : | April 1, 2022 |
| Estimated Study Completion Date : | January 1, 2030 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
Active Comparator: Ablation group
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Drug: rhTSH stimulation
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
Other Name: Thyrogen Drug: I131 An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH. Other: Follow up
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Experimental: Follow up group
Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.
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Other: Follow up
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Primary Outcome Measures :
- Rate of patient without event at 3 years following randomization [ Time Frame: assessed up to 3 years ]
Secondary Outcome Measures :
- Lachrymal and Salivary Glands Toxicities [ Time Frame: Assessed up at baseline, 2 months, 10 months and 3 years after randomization ]
- Patient's quality of life, anxiety and fear of recurrence [ Time Frame: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization ]
- Rate of patients without event [ Time Frame: at 5 years following randomization ]
- Rate of events adjusted on the initial lymph node status [ Time Frame: at 3 and 5 years following randomization ]
- Recurrence rate (histologically proven) [ Time Frame: at 3 years following randomization and then at 5 years ]
- Rate of cure after an event [ Time Frame: at 5 years after randomization ]
- Cost of treatment and follow-up [ Time Frame: at 3 years after randomization ]
- Rate of events adjusted on tumoral molecular characterization [ Time Frame: 3 and 5 years after randomization ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component)
- Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
- Total thyroidectomy performed 2 to 5 months before inclusion
- Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification).
- Post-operative neck ultrasound (performed 2 to 5 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid > 10 ng/mL
- Age >=18 years
- Performance status of 0 or 1
- Patients who signed the informed consent
- Patients who can be followed-up annually during 5 years in order to assess the objectives of the study
- Women of childbearing age should have a negative pregnancy test before any radioiodine administration
- Both patients with or without thyroglobulin antibodies are eligible
Exclusion Criteria:
- Patients having undergone less than a total thyroidectomy
- Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component)
- Patients having undergone total thyroidectomy less than 2 months or more than 5 months before inclusion
- Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010)
- Patient with known distant metastasis
- Abnormal post-operative neck ultrasound of the lateral lymph node compartments
- Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer)
- Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks.
- Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
- Pregnant or breast feeding women
- Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837745
Locations
| France | |
| Institut Gustave Roussy | |
| Villejuif, Val De Marne, France, 94805 | |
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gustave Roussy, Cancer Campus, Grand Paris |
| ClinicalTrials.gov Identifier: | NCT01837745 |
| Other Study ID Numbers: |
2012-A01569-34 2012/1913 ( Other Identifier: CSET number ) |
| First Posted: | April 23, 2013 Key Record Dates |
| Last Update Posted: | May 17, 2023 |
| Last Verified: | May 2023 |
Additional relevant MeSH terms:
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Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |